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Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)

Primary Purpose

Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IPT A Suicide Crisis Intervention
Treatment As Usual
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted

Eligibility Criteria

6 Years - 20 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • depression symptoms
  • suicidal behavior

Exclusion Criteria:

  • acute medical condition
  • intellectual disability
  • cognitive impairment
  • linguistic limitation

Sites / Locations

  • Schneider Children's Medical Center of Israel, Departemnt of Psychological MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

IPT A SCI

Treatment as usual

wait list

Arm Description

The IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails.

TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks.

WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals.

Outcomes

Primary Outcome Measures

Suicide Ideation
suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
change in Depression
Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)

Secondary Outcome Measures

Full Information

First Posted
May 4, 2020
Last Updated
May 26, 2020
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04404322
Brief Title
Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)
Official Title
Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 17, 2018 (Actual)
Primary Completion Date
April 17, 2022 (Anticipated)
Study Completion Date
April 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
To address the critical need in crisis intervention for children and adolescents at suicidal risk the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.
Detailed Description
In recent years, suicidal behaviors have shown substantial increase worldwide. This trend is also prominent in Israel and has led to a dramatic increase in mental health treatment demand resulting in long wait times and low treatment acceptance rate. To address the critical need in crisis intervention for children and adolescents at suicidal risk, the investigators developed an ultra-brief acute crisis intervention, based on Interpersonal Psychotherapy (IPT). IPT is an evidence-based intervention for various psychopathologies among different age groups. The current adaptation of IPT-A is comprised of five weekly sessions, followed by monthly follow-up caring email contacts to the patients and their parents, over a period of three months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Patients are referred to SCMC depression and suicide clinic through the ER, outpatient providers or are self-referred. They undergo an initial evaluation and risk assessment. Following initial evaluation, each subject is assigned to one of three study groups, based on clinical considerations. In this stratified randomization system, the most serious acute cases are generally referred to our ultra-short crisis intervention (IPT- A SCI) and the rest are randomized to either one of the three groups: IPT- A SCI, Treatment as usual (TAU) and waiting list (WL). All participants and their parents complete the questionnaires via a secure electronic interface, with the aid of a trained research assistant. Treatment drop-out rates, thus far, seem low and stand at about 11% for the IPT-A SCI and at about 16% for patients who receive TAU.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPT A SCI
Arm Type
Experimental
Arm Description
The IPT-A SCI follows the intervention protocol, which includes an intensive phase of 5 weekly 50-minute sessions and 3 follow up personal emails.
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
TAU patients receive an integrative combination of psychodynamic, supportive and cognitive behavioural therapy, usually lasting between 10-30 weeks.
Arm Title
wait list
Arm Type
No Intervention
Arm Description
WL patients are monitored by a trained clinician during their waiting period and complete the study questionnaire battery at the parallel time intervals.
Intervention Type
Other
Intervention Name(s)
IPT A Suicide Crisis Intervention
Intervention Description
The intervention is comprised of five weekly sessions followed by monthly emails to the patients and their parents over a period of three months. The first session is aimed at introducing the intervention, assessing depression and suicidal risk and building a safety plan. The safety plan consists of a prioritized list of coping strategies that the patient can use when suicidal risk is increased. The second session is focused on reviewing the patient's interpersonal relationships (using the closeness circle and interpersonal inventory) and conceptualizing the interpersonal problem area. Sessions 3-4 focus on developing and practicing interpersonal, emotional and behavioral coping strategies relevant for suicidal risk. Lastly, in session 5, patient and therapist go over the process and main issues which were worked on, emphasizing relapse prevention by going back to the safety plan. First and fifth sessions always involve the parents.
Intervention Type
Other
Intervention Name(s)
Treatment As Usual
Intervention Description
patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks
Primary Outcome Measure Information:
Title
Suicide Ideation
Description
suicidal ideation [Suicide Ideation Questionnaire (SIQ) (Reynolds, 1987)]
Time Frame
Change from Baseline to 5 weeks assessment and 4 months assessment
Title
change in Depression
Description
Mood and Feeling Questionnaire (MFQ) (Angold et al., 1995)
Time Frame
Change from Baseline to 5 weeks assessment and 4 months assessment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: depression symptoms suicidal behavior Exclusion Criteria: acute medical condition intellectual disability cognitive impairment linguistic limitation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liat Haruvi Catalan, Dr
Phone
0544948037
Email
liatcatalan@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Alan APter, Prof
Email
asapter@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan APTER, Prof
Organizational Affiliation
Rabin MC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
City
Petach Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alan Apter, MD
Email
eapter@clalit.org.il
First Name & Middle Initial & Last Name & Degree
Alan Apter, MD

12. IPD Sharing Statement

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Ultra - Brief Crisis IPT-A Based Intervention for Suicidal Children and Adolescents (IPT-A-SCI)

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